Details for New Drug Application (NDA): 211527
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NDA 211527 describes AKLIEF, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the AKLIEF profile page.
The generic ingredient in AKLIEF is trifarotene. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the trifarotene profile page.
The generic ingredient in AKLIEF is trifarotene. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the trifarotene profile page.
Summary for 211527
| Tradename: | AKLIEF |
| Applicant: | Galderma Labs Lp |
| Ingredient: | trifarotene |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211527
Generic Entry Date for 211527*:
Constraining patent/regulatory exclusivity:
Dosage:
CREAM;TOPICAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 211527
Suppliers and Packaging for NDA: 211527
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AKLIEF | trifarotene | CREAM;TOPICAL | 211527 | NDA | Galderma Laboratories, L.P. | 0299-5935 | 0299-5935-02 | 1 TUBE in 1 BLISTER PACK (0299-5935-02) / 2 g in 1 TUBE |
| AKLIEF | trifarotene | CREAM;TOPICAL | 211527 | NDA | Galderma Laboratories, L.P. | 0299-5935 | 0299-5935-45 | 1 BOTTLE, PUMP in 1 CARTON (0299-5935-45) / 45 g in 1 BOTTLE, PUMP |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.005% | ||||
| Approval Date: | Oct 4, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 4, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jul 19, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Subscribe | Patent Expiration: | Dec 21, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TOPICAL TREATMENT OF ACNE VULGARIS | ||||||||
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